NPPA expert committee recommends retail prices for 24 anti-diabetic drug formulations

The expert committee of the National Pharmaceutical Pricing Authority (NPPA) has recommended retail prices of 24 anti-diabetes drug combinations with components sitagliptin and dapagliflozin, which lost their exclusive patent rights for marketing in the country in recent years, as ingredients. The Multidisciplinary Committee (MDC) of Experts, advising the NPPA on pricing related matters, has recommended retail price fixation for 10 formulations for a combination of sitagliptin 50 mg, metformin hydrochloride 1000 mg and glimepiride 1 mg. Except for Micro Labs Ltd, which claimed a price of Rs. 11.61 per tablet, the prices were fixed at around Rs. 13.35 for the nine other applicants, including Abbott Healthcare, Lupin, Mankind Pharma, Glenmark Pharmaceuticals, Emcure Pharmaceuticals, Torrent Pharmaceuticals, Eris Lifesciences, and Dr Reddy’s Laboratories. The prices were calculated based on the data available with the pricing authority for the month of April and May, 2023, as the applications were filed by the firms during November and December. Retail prices were recommended for another 10 formulations containing sitagliptin 50 mg, metformin hydrochloride 1000 mg and glimepiride 2 mg. While the calculated price for these formulations was at Rs, 15.03 per tablet and for nine of the formulations, the price was fixed at this rate, for Micro Labs, once again, the company claimed a lower price of Rs. 13.39 per tablet, which was then recommended by the Committee. Similarly, Torrent Pharmaceuticals also claimed a lower price of Rs 14.30 per tablet to be manufactured by Exemed Pharmaceuticals and Synokem Pharmaceuticals (in different applications), which was also recommended by the Committee to the Authority for final approval. The other marketers, including Abbott Healthcare, Glenmark Pharmaceuticals, Mankind Pharma, Lupin Ltd, Emcure Pharmaceuticals, Dr Reddy’s Laboratories, Eris Lifesciences, the retail price has been recommended at Rs. 15.03 per tablet. For the combination of dapagliflozin 10mg, glimepiride 2 mg and metformin hydrochloride (as extended release) 500 mg and the same combination with metformin hydrochloride (as extended release) 1000 mg, for Sun Pharma Laboratories, prices were recommended at Rs. 15.15 per tablet and Rs. 16 per tablet. For the combination of dapagliflozin 10mg, glimepiride 1 mg and metformin hydrochloride (as extended release) 500mg, for Sun Pharma the retail price was recommended at Rs. 13.47 per tablet, while for a combination of dapagliflozin 10 mg, glimepiride 1mg and metformin hydrochloride (as extended release) 1000 mg for the company, the retail price was recommended at Rs. 14.50 per tablet. The requests were made by Sun Pharma during the month of October and the prices were calculated based on the market data for the month of March and April, 2023. It may be noted that sitagliptin, for which MSD pharmaceuticals held a patent, expired the patent exclusivity on July 5, 2022.  Sun Pharma was the license holder for the product, according to data from NPPA. Following the expiry of patent, several generic manufacturers came out with combinations containing sitagliptin, which resulted in reduction in the price of these drugs. It may be noted that the NPPA also, during the time, arrived at a methodology under which the prices of the component for which the patent expired recently was calculated 50 per cent reduction. Dapagliflozin, which has witnessed patent expiry on October 2, 2020, has also seen entry of several generic combinations in the market resulting in reduced price for these combinations in the retail market. The patent for dapagliflozin was held by Astra Zeneca, while Sun Pharma and Abbott Healthcare was the license holder for the product.

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